The OnSite HSV-2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) to herpes simplex virus 2 (HSV-2) in human serum, plasma or whole blood. Unique test that utilizes glycoprotein G2 to differentiate between HSV-1. and HSV-2 that allows for an early start of treatment action. Immediate determination of either acute or chronic infection by detecting and differentiating IgG and IgM anti-HSV-2. High confidence as test is in agreement with market leading European ELISA: 95.3% IgG; 100% IgM. Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation. Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial treatment action can begin during patient’s visit as test results are available in 10 minutes. Easily transported, and can be stored for 24 months, 2-30oC. Individually sealed foil pouches containing: One cassette device One desiccant Capillary tubes (10 µL) Sample diluent (REF SB-R0213, 5 mL/bottle) Package insert (instruction for use) CTK Products at a Glance HSV-1 & HSV-2 Flyer Insert U.S. CDC HSV Homepage: Genital Herpes Fact Sheets WHO: Herpes Simplex Virus Fact Sheets

Vitamin B12 Rapid Quantitative Test The Finecare™ Vitamin B12 Rapid Quantitative Test along with Finecare™ FIA Meters is a fluorescence immunoassay quantitative determination of vitamin B12 level in human serum or plasma. The test is used as an aid in the diagnosis of Vitamin B12 deficiency.

INTENDED USE The Finecare™ Estradiol (E2) Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA Meters is for quantitative measurement of Estradiol (E2) in human whole blood, serum or plasma. The test is used as an aid to the evaluation of ovarian diseases. STORAGE AND STABILITY 1. Store the test kit at 4～30℃ up to the expiration date. 2. If removed from refrigerator, allow the test for 30 minutes to return to room temperature before testing. 3. Do not remove the cassette from the pouch until ready to use. The Test cassette should be used within 1 hour once opened.

INTENDED USE The Finecare™ β2-MG Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of β2-MG (Beta-2-Microglobulin) concentration in human plasma, serum or whole blood. The test is used as an aid for the diagnosis of renal disease. STORAGE AND STABILITY 1. Store the test kit at 4℃~30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

INTENDED USE The Finecare™ Lp-PLA2 Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Lp-PLA2 in human serum, plasma or whole blood. The test is used as an aid to the assessment of the coronary heart disease (CHD) and ischemic stroke. STORAGE AND STABILITY 1. Store the test kit at 4℃-30℃ up to the expiration date printed on package. 2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing. 3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.

Finecare™ 2019-nCoV Antigen Test Antigen testing indicates the active infection of 2019-nCoV. For areas with limited PCR resources, antigen testing can be used for aiding in the diagnosis of COVID-19 suspect patients.

INTENDED USE The Finecare™ 2019-nCoV RBD Antibody Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative and semi-quantitative detection of spike receptor-binding domain (RBD) antibodies of novel coronaviruses (2019-nCoV) in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen. The 2019-nCoV RBD antibodies are protective antibody produced by the human body after inoculation with 2019-nCoV vaccine or infection with 2019-nCoV. The test is intended as an aid to assess the adaptive humoral immune response to the 2019-nCoV RBD protein. STORAGE AND STABILITY 1. Store at 4~30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

INTENDED USE The Finecare™ 2019-nCoV lgM/lgG Test is a fluorescence immunoassay used along with Finecare™ FIA Meters for qualitative detection of IgG and IgM antibodies of novel coronaviruses (2019-nCoV) in human whole blood, serum and plasma specimen. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by 2019-nCoV. The test provides preliminary test results. Negative results cannot exclude the possibility of 2019-nCoV infection and they cannot be used as the sole basis for treatment or other management decision. STORAGE AND STABILITY 1. Store at 4-30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze. 2. The test device should be used within 1 hour after taking out from the foil envelope. 3. Keep away from sunlight, moisture and heat. 4. Kit contents are stable until the expiration date printed on the outer box.

HIV 1.2 & Syphilis Combo SERUM/PLASMA/WHOLE BLOOD RAPID TEST HIV 1.2 & Syphilis Combo Serum / Plasma / Whole Blood Rapid Test Type : Device Pack Size : 50 T